Study Stopped
With recommendation from IDMC, Steering Committee terminated this trial due to ethical concerns raised by J-ART study.
Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments
POSITIVE
Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension
1 other identifier
interventional
10,000
1 country
317
Brief Summary
The study is being conducted to compare the effect of standard treatment (target LDL-C level: \<120 mg/dL (JASGL 2007 target level)) and intensive treatment (target LDL-C level: \<70 mg/dL) in the prevention of major adverse cardiac events (MACE) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
317 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 27, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedJune 1, 2011
November 1, 2010
3.9 years
July 27, 2010
May 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
At baseline
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
1 month after treatment initiation
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
3 month after treatment initiation
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
6 month after treatment initiation
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
12 month after treatment initiation
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
36 month after treatment initiation
MACE (time to event): MACE (time to event): myocardial infarction, unstable angina, cardiovascular death, revascularization, fatal/nonfatal cerebrovascular accident, peripheral arteriopathy, aortic event
At the end of the study or discontinuation up to 4 years
Secondary Outcomes (56)
Prevention of individual MACE
At baseline
Prevention of MACE(combination of each category)
At baseline
Prevention, frequency and distribution of type of the following non-MACE cardiac and cerebrovascular events during the study period: heart failure requiring hospitalization, transient ischemic attack (TIA), abnormal ankle-brachial index (abnormal ABI)
At baseline
Frequency and distribution of type of MACE during the study period Including correlation with LDL-C, HDL-C and LDL-C/HDL-C ratio (hereafter referred to as "L/H ratio")
At baseline
Frequency and distribution of type of deaths during the study period
At baseline
- +51 more secondary outcomes
Study Arms (2)
Active comparator: Standard Pravastatin Group
ACTIVE COMPARATORIntensive Rosuvastatin Group
ACTIVE COMPARATORInterventions
5 mg/day or 10 mg/day of pravastatin will be administered orally for 36 months, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of \<120 mg/dL (JASGL 2007 target level) as quickly as possible. (Maximum dose increase of pravastatin: 20 mg/day)
5 mg/day or 10 mg/day of rosuvastatin will be administered orally for 36 months based on the LDL-C level of the subject, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of \<70 mg/dL as quickly as possible. (Maximum dose increase to rosuvastatin: 20 mg/day)
Eligibility Criteria
You may qualify if:
- Patients giving voluntary written consent to participate in the study
- Male or female patients 50 years of age or older (at informed consent)
- Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL)
- Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy)
- Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy)
- Patients with two or more of the following risk factors
- Male
- years of age or older
- Smoker
- L/H ratio: ≥3.0 •HbA1c level: ≥8.0%
- Left ventricular hypertrophy
- First- or second-degree family history of MACE
- Microalbuminuria (quantitative testing: ≥30 mg/dL), proteinuria (qualitative testing: + or higher) or eGFR (\<60 mL/min/1.73 m2)
You may not qualify if:
- Patients meeting the following criteria will be excluded from the study:
- Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent
- Patients judged to have familial hypercholesterolemia
- Patients with a serum triglyceride level of ≥400 mg/dL
- Patients with a history of myocardial infarction
- Patients with a history of coronary revascularization (PCI or CABG)
- Patients with a history of treatment of unstable angina
- Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction)
- Heart failure patients
- Patients with a history of hypersensitivity to statins
- Patients with a history of drug-induced myopathy
- Patients with poorly controlled arrhythmia
- Patients with severe liver or kidney disease
- Patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan
- Patients who are or may be pregnant
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (317)
Hiramitsu Heart Clinic
Nagoya, Aichi Pref., Japan
Medical Dock&Clinic
Nagoya, Aichi Pref., Japan
Matsuno Medical Clinic
Iyo Gun, Ehime Pref., Japan
Ishite Matsumoto Naika Junkanki Clinic
Matsuyama, Ehime Pref., Japan
Ehime Medical CO-OP Izumigawa Clinic
Niihama, Ehime Pref., Japan
Tsugawa Internal Medicine Clinic
Echizen, Fukui Pref., Japan
Fukui Chuo Clinic
Fukui, Fukui Pref., Japan
Koshino Clinic
Sakai, Fukui Pref., Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka Pref., Japan
Saiseikai Futsukaichi Hospital
Chikushino-shi, Fukuoka Pref., Japan
Abies Clinic
Fukuoka, Fukuoka Pref., Japan
Hirano Medical Clinic
Fukuoka, Fukuoka Pref., Japan
Naitoh Clinic
Fukuoka, Fukuoka Pref., Japan
Saku Hospital
Fukuoka, Fukuoka Pref., Japan
Fukuoka Tokushukai Medical Center
Kasuga, Fukuoka Pref., Japan
Morizono Naika
Kitakyushu, Fukuoka Pref., Japan
Kawai Naika Clinic
Gifu, Gifu Pref., Japan
Hiroshima General Hospital of West Japan Railway Company
Hiroshima, Hiroshima Pref., Japan
Hijirigaoka Hospital
Date, Hokkaido Pref., Japan
Kyoaikai Hospital
Hakodate, Hokkaido Pref., Japan
Miyazawa Cardiovascular And Internal Medicine Clinic
Kato-gun, Hokkaido Pref., Japan
Jiyugaoka Yamada Clinic
Obihiro, Hokkaido Pref., Japan
Chikama Clinic
Sapporo, Hokkaido Pref., Japan
Hiro Clinic
Sapporo, Hokkaido Pref., Japan
Medical and Radiology Clinic Caress Sapporo Hokko Memorial Hospital
Sapporo, Hokkaido Pref., Japan
Seiwa Memorial Hospital
Sapporo, Hokkaido Pref., Japan
Medical Treatment Corporate Foundation Yubari Kibounomori Yubari City Clinic
Yūbari, Hokkaido Pref., Japan
Ino Hospital
Himeji, Hyogo Pref., Japan
Katsuya Clinic
Amagasaki, Hyogo Pref, Japan
Kotani Diabetes Clinic
Kobe, Hyogo Pref, Japan
Shimizu Clinic
Kobe, Hyogo Pref, Japan
Dr. Kodama's Office of Internal Medicine
Nishinomiya, Hyogo Pref, Japan
Koga Hospital
Koga, Ibaraki Pref., Japan
Imura Internal Medicine Clinic
Hakusan, Ishikawa Pref., Japan
Yanagi Medical Clinic
Hakusan, Ishikawa Pref., Japan
Okyozuka Clinic
Ishikawa Gun, Ishikawa Pref., Japan
Koni Clinic
Kahoku Gun, Ishikawa Pref., Japan
Murata Clinic
Kahoku Gun, Ishikawa Pref., Japan
Arai Naika Clinic
Kanazawa, Ishikawa Pref., Japan
Dr. Hayakawa's Family Clinic
Kanazawa, Ishikawa Pref., Japan
Wakasa Medical Clinic
Kanazawa, Ishikawa Pref., Japan
Morita Hospital
Komatsu, Ishikawa Pref., Japan
Kawasaki Family Clinic
Ichinoseki, Iwate Pref., Japan
Sugie Clinic
Iwate Gun, Iwate Pref., Japan
Katsura General Clinic
Morioka, Iwate Pref., Japan
Takamiya General Clinic
Shiwa Gun, Iwate Pref., Japan
Hayashi Clinic
Marugame, Kagawa Pref., Japan
Otsuka Internal Medicine Clinic
Marugame, Kagawa Pref., Japan
Center for Preventive Medical Treatment, NTT West Takamatsu Hospital
Takamatsu, Kagawa Pref., Japan
Hananomiya Clinic
Takamatsu, Kagawa Pref., Japan
Hasegawa Outpatients Clinic for Cardiovascular Disease
Takamatsu, Kagawa Pref., Japan
Kojima Clinic
Takamatsu, Kagawa Pref., Japan
Matsuoka Clinic
Takamatsu, Kagawa Pref., Japan
Osumi-Kanoya Hospital
Kanoya, Kagoshima Pref., Japan
Yakushima Tokushukai Hospital
Kumage Gun, Kagoshima Pref., Japan
Nemoto G.I.M. Clinic
Ashigara-kami Gun, Kanagawa Pref., Japan
Magokoro Internal Medicine and Orthopedic Clinic
Ashigarakami Gun, Kanagawa Pref., Japan
Kasuya Clinic
Atsugi, Kanagawa Pref., Japan
Kuboshima Clinic
Fujisawa, Kanagawa Pref., Japan
Takahashi Clinic
Fujisawa, Kanagawa Pref., Japan
Akizawa Clinic
Isehara, Kanagawa Pref., Japan
Medical Corp Takeda Clinic
Isehara, Kanagawa Pref., Japan
Hashimoto Clinic
Kamakura, Kanagawa Pref., Japan
Iroden Clinic
Kamakura, Kanagawa Pref., Japan
Kamakura Naika Shinryosyo
Kamakura, Kanagawa Pref., Japan
Shohei Clinic
Kamakura, Kanagawa Pref., Japan
Hatori Medical Clinic
Kawasaki, Kanagawa Pref., Japan
Hirayasu Iin
Kawasaki, Kanagawa Pref., Japan
Kamegaya Medical Clinic
Kawasaki, Kanagawa Pref., Japan
Kirimura Iin
Kawasaki, Kanagawa Pref., Japan
Kojima Clinic
Odawara, Kanagawa Pref., Japan
Hakuai Iin
Sagamihara, Kanagawa Pref., Japan
Sato Clinic
Sagamihara, Kanagawa Pref., Japan
Toshiba Rinkan Hospital
Sagamihara, Kanagawa Pref., Japan
Yamamoto Clinic
Sagamihara, Kanagawa Pref., Japan
Fukumura Clinic
Yokohama, Kanagawa Pref., Japan
Fukushi Clinic
Yokohama, Kanagawa Pref., Japan
International Goodwill Hospital
Yokohama, Kanagawa Pref., Japan
Kikuchi Clinic
Yokohama, Kanagawa Pref., Japan
Matsuo Naika Clinic
Yokohama, Kanagawa Pref., Japan
Miho-cho Cardiovascular Medical Clinic
Yokohama, Kanagawa Pref., Japan
Minamisawa Clinic
Yokohama, Kanagawa Pref., Japan
Miyoshi-Clinic
Yokohama, Kanagawa Pref., Japan
Paula's Clinic
Yokohama, Kanagawa Pref., Japan
Shimokurata Heart Clinic
Yokohama, Kanagawa Pref., Japan
Shinwakai Fukuda Iin
Yokohama, Kanagawa Pref., Japan
Shinyoshida Clinic
Yokohama, Kanagawa Pref., Japan
Suzuki Orthopedic Clinic
Yokohama, Kanagawa Pref., Japan
Yokohama City University Medical Center
Yokohama, Kanagawa Pref., Japan
Yokohama Sotetsu bldg. clinic of internal medicine
Yokohama, Kanagawa Pref., Japan
Hara Clinic
Yokosuka, Kanagawa Pref., Japan
Ueta Medical Clinic
Kochi, Kochi Pref., Japan
Nakayama Cardiovascular Clinic
Amakusa, Kumamoto Pref., Japan
Yamashita Clinic
Amakusa, Kumamoto Pref., Japan
National Health Insurance Central Hospital Aso
Aso, Kumamoto Pref., Japan
Sakanashi Heart Clinic
Aso, Kumamoto Pref., Japan
Koyasako iin
Kamimashiki Gun, Kumamoto Pref., Japan
Kawaguchi Hospital
Kikuchi, Kumamoto Pref., Japan
Miyamoto Internal Clinic
Kikuchi, Kumamoto Pref., Japan
Doi Cardiovascular Clinic
Kumamoto, Kumamoto Pref., Japan
Doi Naika-ichoka Clinic
Kumamoto, Kumamoto Pref., Japan
Haraguchi Circular&Internal Medical Clinic
Kumamoto, Kumamoto Pref., Japan
Jinnouchi Clinic Diabetes Care Center
Kumamoto, Kumamoto Pref., Japan
Kiyota Junkanki Naika Iin
Kumamoto, Kumamoto Pref., Japan
Maki Cardiovascular Clinic
Kumamoto, Kumamoto Pref., Japan
Nozuhara Clinic
Kumamoto, Kumamoto Pref., Japan
Ootsuka Hospital
Kumamoto, Kumamoto Pref., Japan
Shono Heart Clinic
Kumamoto, Kumamoto Pref., Japan
Suefuji Naika Junkankika
Kumamoto, Kumamoto Pref., Japan
Suizenji Tohya Hospital
Kumamoto, Kumamoto Pref., Japan
Terao Hospital
Kumamoto, Kumamoto Pref., Japan
Yi Medical Clinic
Kumamoto, Kumamoto Pref., Japan
Munakata Clinic
Shimomashiki Gun, Kumamoto Pref., Japan
Higashi Diabetes and Cardiovascular Clinic
Tamana, Kumamoto Pref., Japan
Yoshimura Jyunnkannkika Naika Iinn
Tamana, Kumamoto Pref., Japan
Universal Shipbuilding Co. Ariake Shipyard Ariake Infirmary
Tamana Gun, Kumamoto Pref., Japan
Miyagi Clinic Cardiovascular Medicine
Yatsushiro, Kumamoto Pref., Japan
Koide Iin
Kizugawa, Kyoto Pref., Japan
Asamoto Clinic of Internal Medicine
Kyoto, Kyoto Pref., Japan
Gotoh Clinic
Kyoto, Kyoto Pref., Japan
Higashiyama Takeda Hospital
Kyoto, Kyoto Pref., Japan
Isoda Internal Medical Clinic
Kyoto, Kyoto Pref., Japan
Omoto Clinic
Kyoto, Kyoto Pref., Japan
Sakazaki Clinic
Kyoto, Kyoto Pref., Japan
Shinya Clinic
Kyoto, Kyoto Pref., Japan
Takagi Cardiology Clinic
Kyoto, Kyoto Pref., Japan
Takenaka Clinic
Kyoto, Kyoto Pref., Japan
Tegoshi Clinic
Kyoto, Kyoto Pref., Japan
Sawai medical Clinic
Kyōtanabe, Kyoto Pref., Japan
Kimura Naika Clinic
Yosa Gun, Kyoto Pref., Japan
Shimizu Clinic
Ise, Mie Pref., Japan
Horii Clinic Kiodai
Nabari, Mie Pref., Japan
Yamoto-naika Clinic
Higashi Matsushima City, Miyagi Pref., Japan
Seisuikai Yoshioka QQ Clinic
Kurokawa Gun, Miyagi Pref., Japan
Ohtomo Clinic
Tome, Miyagi Pref., Japan
Shimoina Kosei Hospital
Shimoina Gun, Nagano Pref., Japan
Yokoyama Medical Clinic
Shiojiri, Nagano Pref., Japan
Sato Clinic
Suzaka, Nagano Pref., Japan
Hoshiko Clinic
Nagasaki, Nagasaki Pref., Japan
Shinagawa Clinic
Nagasaki, Nagasaki Pref., Japan
Iryohojin Yamamoto Naika
Nishisonogi Gun, Nagasaki Pref., Japan
Yamada Clinic
Gojō, Nara Pref., Japan
Uyama Naika Clinic
Ikoma, Nara Pref., Japan
Clinic Jinguumae
Kahihara City, Nara Pref., Japan
Kasahara Clinic
Kahihara City, Nara Pref., Japan
Sawada Clinic
Kashiba, Nara Pref., Japan
Doi Clinic
Kashihara, Nara Pref., Japan
Medical Corporation Kiriyama Clinic
Kashihara, Nara Pref., Japan
Miyamoto Clinic
Kashihara, Nara Pref., Japan
Oosumi Naika Iin
Kashihara, Nara Pref., Japan
Kondo Clinic Mamigaoka Purified Center
Kitakatsuragi Gun, Nara Pref., Japan
Matsuoka Clinic
Kitakatsuragi Gun, Nara Pref., Japan
Nakahori Iin
Kitakatsuragi Gun, Nara Pref., Japan
Seiwadai Clinic
Kitakatsuragi Gun, Nara Pref., Japan
Saiseikai Nara Hospital
Nara, Nara Pref., Japan
Takanohara Central Hospital
Nara, Nara Pref., Japan
Takanohara Suzuran-naika
Nara, Nara Pref., Japan
Ote Clinic of Internal Medicine
Sakurai, Nara Pref., Japan
Sakaguchi Clinic
Sakurai, Nara Pref., Japan
Kokuho Central Hospital
Shiki Gun, Nara Pref., Japan
Makiura Naika
Yamatokōriyama, Nara Pref., Japan
Matsuta Heart Clinic
Yamatokōriyama, Nara Pref., Japan
Nakatani Clinic
Yamatotakada City, Nara Pref., Japan
Sano Clinic
Murakami, Niigata Pref., Japan
Kawaguchi Clinic
Nagaoka, Niigata Pref., Japan
Maeda Medical Clinic
Niigata, Niigata Pref., Japan
Watanabe NJ Clinic
Beppu, Oiat Pref., Japan
Hirata Clinic
Ōita, Oiat Pref., Japan
Ninomiya Clinic
Ōita, Oiat Pref., Japan
Sumi Cardiology Clinic
Ōita, Oiat Pref., Japan
Tokumaru Digestive Internal Medicine Clinic
Ōita, Oiat Pref., Japan
Tsuzaki Clinic
Ōita, Oiat Pref., Japan
Ishida Medical Clinic
Usa, Oiat Pref., Japan
Hachiouji Naika Clinic
Kurashiki, Okayama Pref., Japan
Inada Clinic
Kurashiki, Okayama Pref., Japan
Hisamatsu Medical Clinic
Okayama, Okayama Pref., Japan
Yuhara Naika Clinic
Okayama, Okayama Pref., Japan
Hattori Clinic
Setouchi, Okayama Pref., Japan
Nishimura Clinic
Fujiidera, Osaka Pref., Japan
Ikeda Clinic
Higashiosaka, Osaka Pref., Japan
Ogawa Clinic
Higashiosaka, Osaka Pref., Japan
Taisei Clinic
Hirakata, Osaka Pref., Japan
Ishiga Clinic
Ibaraki, Osaka Pref., Japan
Masuda Clinic
Ibaraki, Osaka Pref., Japan
Kanazawa Clinic
Izumi, Osaka Pref., Japan
Misugi Clinic
Kaizuka, Osaka Pref., Japan
Yoshida Clinic
Kaizuka, Osaka Pref., Japan
Mori Iin
Kishiwada, Osaka Pref., Japan
Medical Corporation Joukokai Teranishi-geka naika
Moriguchi, Osaka Pref., Japan
Iryouhoujin Suisyoukai Murata Hospital
Osaka, Osaka Pref., Japan
Izuoka Clinic
Osaka, Osaka Pref., Japan
Keiju Hospital
Osaka, Osaka Pref., Japan
Kondo Clinic
Osaka, Osaka Pref., Japan
Kubota Clinic
Osaka, Osaka Pref., Japan
Matsushita Medical Clinic
Osaka, Osaka Pref., Japan
Nishizawa Clinic
Osaka, Osaka Pref., Japan
Osaka General Medical Center
Osaka, Osaka Pref., Japan
Senpuku Clinic
Osaka, Osaka Pref., Japan
Tai Internal Medicin Clinic
Osaka, Osaka Pref., Japan
Ueda Clinic
Osaka, Osaka Pref., Japan
Ohta Iin
Sakai, Osaka Pref., Japan
Ban Clinic
Suita, Osaka Pref., Japan
Iryohojin Nogi Naika Iin
Suita, Osaka Pref., Japan
Kobayashi Clinic
Suita, Osaka Pref., Japan
Ichida Internal Clinic
Takaishi, Osaka Pref., Japan
Yada Clinic
Takaishi, Osaka Pref., Japan
Ryo Clinic
Takatsuki, Osaka Pref., Japan
Matsuo Clinic
Yao, Osaka Pref., Japan
Enomoto Clinic
Ageo, Saitama Pref., Japan
Medimo Hanyu Clinic
Hanyū, Saitama Pref., Japan
Hirose Hospital
Kawagoe, Saitama Pref., Japan
Iryohojin Hogi Shinryojo
Kawaguchi, Saitama Pref., Japan
Tokutake Iin
Kawaguchi, Saitama Pref., Japan
Gamo Tenjinbashi Clinic
Koshigaya, Saitama Pref., Japan
Matsumoto Clinic
Koshigaya, Saitama Pref., Japan
Medical Corporation Shibuya Clinic
Kumagaya, Saitama Pref., Japan
Akimoto Clinic
Saitama, Saitama Pref., Japan
Iwatsuki-minami Hospital
Saitama, Saitama Pref., Japan
Suzuhiro Clinic
Saitama, Saitama Pref., Japan
Nashida naika clinic
Tokorozawa, Saitama Pref., Japan
Shizuoka Medical Alliance Shirahama Chuou Clinic
Shimoda, Shizuoka Pref., Japan
Akiyama Clinic
Shizuoka, Shizuoka Pref., Japan
Aoshima Clinic
Shizuoka, Shizuoka Pref., Japan
Eguchi Clinic
Shizuoka, Shizuoka Pref., Japan
Shizuoka Hospital
Shizuoka, Shizuoka Pref., Japan
Ueno Clinic
Yaizu, Shizuoka Pref., Japan
Takahashi Medical Clinic
Ohtawara City, Tochigi Pref., Japan
Iryouhoujin Yuukoukai Morioka Naika Shonika
Oyama, Tochigi Pref., Japan
Takada Clinic
Tochigi, Tochigi Pref., Japan
Masuda Naika
Utsunomiya, Tochigi Pref., Japan
Murakami Clinic
Anan, Tokushima Pref., Japan
Fukushima Clinic
Itano Gun, Tokushima Pref., Japan
Yamamoto Naika Ityoka
Itano Gun, Tokushima Pref., Japan
Yuki National Health Insurance Hospital Of Minami Town
Kaifu Gun, Tokushima Pref., Japan
Sekishinkan Hospital
Komatsushima, Tokushima Pref., Japan
Ueta Clinic
Myozai Gun, Tokushima Pref., Japan
Kensei Uchimachi Clinic
Tokushima, Tokushima Pref., Japan
Kitagawa Naika Ityoka
Tokushima, Tokushima Pref., Japan
Kitasako Clinic
Tokushima, Tokushima Pref., Japan
Limbs Tokushima Clinic
Tokushima, Tokushima Pref., Japan
Matsumura Internal, Gastrointestial Medicine
Tokushima, Tokushima Pref., Japan
Okagawa Clinic
Tokushima, Tokushima Pref., Japan
Yokoi Internal Medicine
Tokushima, Tokushima Pref., Japan
Kimura Internal Medicine Clinic
Yoshinokawa City, Tokushima Pref., Japan
Yata Clinic
Yoshinokawa City, Tokushima Pref., Japan
Okubo Clinic
Akishima, Tokyo, Japan
Juntendo University Hospital
Bunkyo Ku, Tokyo, Japan
Choei Clinic
Edogawa Ku, Tokyo, Japan
Shiraishi Iin
Edogawa Ku, Tokyo, Japan
Hattori Clinic
Hachiōji, Tokyo, Japan
Toyoizumi Hospital
Hachiōji, Tokyo, Japan
Utsugidai Tajima Clinic
Hachiōji, Tokyo, Japan
Mochizuki Naika Clinic
Itabashi Ku, Tokyo, Japan
Nishio Clinic
Itabashi Ku, Tokyo, Japan
Ono Heart Clinic
Koto Ku, Tokyo, Japan
Shiba Palace Clinic
Minato-ku, Tokyo, Japan
Kamada Clinic
Mitaka, Tokyo, Japan
Tenjinmae Clinic
Mitaka, Tokyo, Japan
Takayama Iin
Mitaka-shi, Tokyo, Japan
Sugawara Clinic
Nerima Ku, Tokyo, Japan
Yamada Clinic
Ōta-ku, Tokyo, Japan
Matsumura Gastroenterological Clinic
Setagaya Ku, Tokyo, Japan
Magari Clinic
Shinjuku Ku, Tokyo, Japan
Yotsuya Internal Medicine Clinic
Shinjuku Ku, Tokyo, Japan
Yotsuya-Murakami Internal Medicine Clinic
Shinjuku Ku, Tokyo, Japan
Obayashi Clinic
Sumida City, Tokyo, Japan
Sumidagawa Clinic
Sumida Ku, Tokyo, Japan
ISHII Medical Clinic
Tachikawa-shi, Tokyo, Japan
Takahashi Ko Minako Clinic
Murayama, Yamagata Pref., Japan
Obanazawa City Clinic
Obanazawa, Yamagata Pref., Japan
Okuyama Clinic
Obanazawa, Yamagata Pref., Japan
Sakae Clinic
Obanazawa, Yamagata Pref., Japan
Honma Clinic
Sakata, Yamagata Pref., Japan
Isoda Clinic
Yamagata, Yamagata Pref., Japan
Nihei Clinic
Yamagata, Yamagata Pref., Japan
Shimasaki Clinic
Yamagata, Yamagata Pref., Japan
Yamagata Tokushukai Hospital
Yamagata, Yamagata Pref., Japan
Iwasaki Naika Iin
Iwakuni, Yamaguchi Pref., Japan
Kuwahara Clinic
Iwakuni, Yamaguchi Pref., Japan
Ayame Medical Clinic
Shimonoseki, Yamaguchi Pref., Japan
Johno Clinic
Shimonoseki, Yamaguchi Pref., Japan
Matsuda Medical Clinic
Shimonoseki, Yamaguchi Pref., Japan
Mizumachi Medical Clinic
Shimonoseki, Yamaguchi Pref., Japan
Noda Clinic
Shimonoseki, Yamaguchi Pref., Japan
Fujii Clinic
Ube, Yamaguchi Pref., Japan
Shakaiiryouhoujin Onaka Hospital
Ube, Yamaguchi Pref., Japan
Watada-naika Hospital
Ube, Yamaguchi Pref., Japan
Ouchi Clinic
Yamaguchi, Yamaguchi Pref., Japan
Yoshizaki Clinic
Chūō, Yamanashi Pref., Japan
Takahashi Clinic
Nishi Yatsushiro Gun, Yamanashi Pref., Japan
Higashikatsura Medical Clinic
Tsuru, Yamanashi Pref., Japan
Fukushi Clinic
Aomori, Japan
Kashiwagi Clinic
Ayase, Japan
Hayashi Diabetes Clinic
Chigasaki, Japan
Uchiyama Clinic
Jōetsu, Japan
Nitta Medical Clinic
Kamiinagun, Japan
Imai Clinic
Kawasaki, Japan
Tani Clinic
Kitakyushu, Japan
Marumo Clinic
Koganei, Japan
Ihara Clinic
Kyoto, Japan
Goko-Hospital
Matsudo, Japan
Satou Clinic
Mooka, Japan
Iino Clinic
Nirasaki, Japan
Miura Clinic
Osaka, Japan
Kuroda Iin
Ōtsuki, Japan
Sasaki Clinic
Sendai, Japan
Kamata Clinic of Internal Medicine
Shiki, Japan
Nishikawa Clinic
Shimoda, Japan
Satou Iin
Shimoinagun, Japan
Kumagai Clinic
Shinshiro, Japan
Suzuki Clinic
Toyokawa, Japan
Benibana Clinic
Yamagata, Japan
Fujimi Clinic
Yokohama, Japan
Hongo Clinic
Yokohama, Japan
Jiyukai Yamada Naika
Yokohama, Japan
Shonan Ochanomizu Clinic
Yokohama, Japan
Tani Clinic Internal Medicine, Allergology & Rheumatology
Yokohama, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 27, 2010
First Posted
August 2, 2010
Study Start
July 1, 2010
Primary Completion
June 1, 2014
Last Updated
June 1, 2011
Record last verified: 2010-11